Currently browsing posts about: Supplements

Jung J-S, Choi G-H, Lee H, Ko Y, Ji S. The Clinical Effect of a Propolis and Mangosteen Extract Complex in Subjects with Gingivitis: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial. Nutrients 2024, 16(17), 3000; https://doi.org/10.3390/nu16173000

Results:  The results revealed that the PMEC group showed a significantly reduced expression of all measured GCF biomarkers compared to the placebo group (p < 0.0001) at 8 weeks, including substantial reductions in IL-1β, PGE2, MMP-8, and MMP-9 levels compared to the baseline. While clinical parameters trended towards improvement in both groups, the intergroup differences were not statistically significant.

Conclusion: These findings suggest that PMEC consumption can attenuate gingival inflammation and mitigate periodontal tissue destruction by modulating key inflammatory mediators in gingival tissue.

Funding: This research was funded by Medibio Lab Co., Ltd.

Conflicts of interest: The authors declare no conflicts of interest. The authors declare that this study received funding from Lab Co., Ltd. The funders had no role in the design of this study; in the collection, analyses, or interpretation of data; in the writing of this manuscript; or in the decision to publish the results.

Comment: This is a typical industry-funded study in which the authors put a positive interpretation of what appear to be null findings.  I can’t quite tell what this sponsoring company is.  One possibility is MediBioKorea.  Another is Medibios.  Both make supplements.

No food industry is too small or too obscure to fund research in its own interest.  Try this one, for example.

Effects of Supplementation with a Microalgae Extract from Phaeodactylum tricornutum Containing Fucoxanthin on Cognition and Markers of Health in Older Individuals with Perceptions of Cognitive Decline. Yoo C, Maury J, Gonzalez DE, Ko J, Xing D, Jenkins V, Dickerson B, Leonard M, Estes L, Johnson S, et al.  Nutrients. 2024; 16(17):2999. https://doi.org/10.3390/nu16172999

Background: Phaeodactylum tricornutum (PT) is a microalgae extract that contains fucoxanthin and has been shown to enhance cognitive function in younger populations.

Purpose: The present study assessed if PT supplementation affects cognition in healthy, young-old, physically active adults with self-perceptions of cognitive and memory decline.

Methods: Forty-three males and females…with perceptions of cognitive and memory decline completed the double-blind, randomized, parallel-arm, placebo-controlled intervention clinical trial. Participants were…randomly allocated to their respective 12-week supplementation interventions, which were either the placebo (PL) or 1100 mg/day of PT containing 8.8 mg of fucoxanthin (FX).

Results: FX supplementation significantly affected (p < 0.05) or exhibited tendencies toward significance (p > 0.05 to p < 0.10 with effect sizes ranging from medium to large) for word recall, picture recognition reaction time, Stroop color–word test, choice reaction time, and digit vigilance test variables.

Conclusions: The results demonstrate some evidence that FX supplementation can improve working and secondary memory, vigilance, attention, accuracy, and executive function.

Funding: Microphyt (Baillargues, FRA) funded this study through a grant (Microphyt #410991) to Texas A&M University.

Conflicts of interest: J.M. and R.P. are sponsor-affiliated researchers who therefore have conflicts of interest in study results. They provided input on study design but were not involved in data collection or analysis. R.B.K. has conducted grant and contract-funded research on nutritional supplements awarded to the universities he has been affiliated with, received an honorarium for making scientific presentations, and served as a paid scientific expert. He has no financial conflicts of interest with the study sponsor or product evaluated in this study. The remaining coauthors report no financial conflicts of interest.

Comment: I like “some evidence.”  That suggests the evidence is not particularly impressive.  The study found positive conclusions, not surprising since two of the authors work for the sponsoring company.  Industry-funded studies almost invariably find conclusions that favor the sponsor’s interests.  Otherwise, why bother to sponsor research.  That’s its point: marketing.

I read about this one in NutraIngredients.  To its credit, it identified the funder right in the headline:

Krill oil may boost skin health measures, say two new RCTs from Aker BioMarine: Krill oil supplementation may strengthen skin barrier function and improves hydration and elasticity of the skin in healthy adults, according to data from two new pilot studies.

I went right to the study: Krill oil supplementation improves transepidermal water loss, hydration and elasticity of the skin in healthy adults: Results from two randomized, double-blind, placebo-controlled, dose-finding pilot studies.  Katina Handeland PhD, Mike Wakeman MSc, MRPharmS, Lena Burri PhD.  J Cosmetic Dermatology.  https://doi.org/10.1111/jocd.16513

Purpose: to see whether krill oil, which contains omega-3 fatty acids, improves skin hydration and elasticity.

Methods: in two randomized, double-blind, placebo-controlled, pilot studies, participants consumed 1 or 2 g of krill oil or placebo daily.  The outcomes were assessed at baseline, 6 and 12 weeks.

Results: the group supplemented with krill oil did better.

Conclusions: “Daily oral supplementation with 1 and 2 g of krill oil showed significant and dose-dependent improvements in skin TEWL, hydration, and elasticity compared to placebo that correlated with changes in the omega-3 index.

Conflicts of interest: “KH and LB are employees of Aker BioMarine Human Ingredients AS that has provided the krill and placebo oil and funded the study.”

Comment: Krill oil?  That’s a new one for me.  Krill are crustaceans, plankton, at the bottom of the marine food chain; they are a primary food source for baleen whales.  I quickly found krill oil supplements to be widely available (“dynamic,” “antarctic,” “help to reduce heart disease, strokes, inflammation”) at impressive cost.  Despite claims for a vast array of benefits, I’m dubious about the value of getting omega-3s from supplements.  The manufacturer of these supplements did this study to back up another sales pitch.  As I keep saying, these kinds of studies are primarily about marketing, not science.

I definitely wanted to read more of this article from the newsletter, NutrIngredients-Europe:

ASA targets menopause claims with AI assisted crackdown:  The UK’s advertising standards authority (ASA) has warned supplement firms they must remove ads which make claims to treat or cure the symptoms of menopause, as part of a wider AI-assisted campaign…. Read more

Apparently, the UK’s version of our Federal Trade Commission is using artificial intelligence to monitor supplement advertising claims.   The AI system picked up ads for supplements made by Rejuvit Labs and FemTech Healthcare.

An ad for Rejuvit Menopause Relief supplement

included a customer testimonial that stated, “round 2-8 weeks after my first capsule, I already had extra room in my pants (everyone was asking how I lost weight), I felt more energized, and the hot flashes [sic] were gone […] I just keep feeling better, healthier, and happier.”

The ASA stated: “We considered that consumers would understand these to be claims that the product could treat symptoms of menopause, including resolving menopause-related weight gain, increasing energy levels and stopping hot flashes.”

The ASA takes a dim view of non-medical “cures” for menopausal symptoms and is going after them.

With AI algorithms!

It’s a brave new world out there.

Much fuss is being made over this study: Loftfield E, O’Connell CP, Abnet CC, Graubard BI, Liao LM, Beane Freeman LE, Hofmann JN, Freedman ND, Sinha R. Multivitamin Use and Mortality Risk in 3 Prospective US Cohorts. JAMA Netw Open. 2024 Jun 3;7(6):e2418729. doi: 10.1001/jamanetworkopen.2024.18729.

Key Points

Question  What is the association between long-term, daily multivitamin use and mortality in generally healthy adults?

Findings  In this cohort study of 390 124 generally healthy adults with more than 20 years of follow-up, daily multivitamin use was not associated with a mortality benefit.

Meaning  These findings suggest that multivitamin use to improve longevity is not supported.

Here’s the summary:

The investigators did not find any associated benefit of multivitamins for mortality.  If anything, there is a slight association with increased risk.

In this cohort study of 390 124 generally healthy US adults with more than 20 years of follow-up, daily MV use was not associated with a mortality benefit. In contrast, we found that daily MV use vs nonuse was associated with 4% higher mortality risk.

Comment

Nobody should be surprised by this result.  Lots of other studies also suggest that multivitamin supplements do not make healthy people healthier.  Healthy people are most likely to take such supplements in the belief that they might help and can’t hurt.

This study says they won’t help.  If they do hurt, it won’t be by much.

I doubt the study will make much difference to supplement takers.  Supplements are about belief, not science.

I am indebted to NutraIngredients-Europe for this collection of articles on the trendy herbal supplement, ashwagandha.

Ashwaganda is one of those supplements said to do wonders for stress and anxiety (of which we all have lots these days) and sleep (also a common problem).

The Ashwagandha plant is native to India, northern Africa, and the Middle East—but is now grown around the world. While the whole plant is cultivated, the root and leaf are used in extracts. Ashwagandha is a traditional herb long used for its adaptogenic properties to help your body adapt to stressors. Adaptogens are plants that facilitate your body’s ability to adapt to stress.

The NIH Office of Dietary Supplements says

Ashwagandha appears to be well tolerated for up to 3 months of use. However, the efficacy and safety of long-term ashwagandha use over months or years for stress, anxiety, or sleep is not known. In addition, ashwagandha may have potential adverse effects on the liver and thyroid and might not be safe for people with prostate cancer or those who are pregnant or nursing.

What is especially interesting are the contradictory views of this supplement.  Some see benefits.  Others see risks.

The purported benefits

• Study: Ashwagandha effectively relieves chronic stress: Standardized root and leaf aqueous ashwagandha extract safely and effectively reduces stress in chronically stressed people, according to a new study…. Read more
• Ashwagandha intake linked to memory and attention benefits: Acute and repeated supplementation with liposomal ashwagandha may boost select cognitive effects, including memory, attention, vigilance and reaction time in healthy adults, says a new study…. Read more
• Review reveals benefits of ashwagandha on ‘inflammaging’: A new synthetic review on ashwagandha (Withania somnifera, or WS) has underlined the herb’s potential for treating ‘inflammaging’—persistent low-grade inflammation linked to aging…. Read more

The risks

• French agency warns ashwagandha unsafe in specific populations: The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has warned against the use of ashwagandha in a number of specific populations, making it likely operators will be advised to use label warnings…. Read more
• European food safety report ‘taking pot shots’ at popular botanicals: A working group of 26 member states has published a report suggesting the need to ban or restrict 12 ‘critical’ ingredients such as ashwagandha, curcumin, maca and substances like melatonin…. Read more

The debate

• AHP responds to claims of ashwagandha abortifacient effects: The American Herbal Pharmacopoeia (AHP) has responded to the growing number of European authorities reporting ashwagandha as an abortificient, arguing they have incorrectly cited the WHO monograph and AHP review…. Read more
• Ashwagandha concerns branded pure ‘horse s**t’: On-trend herb thrives despite authority unease: While ashwagandha investment and innovation is surging, some European authorities are showing signs of safety concern, leading industry experts to criticize a spread of “complete misinformation” across the continent…. Read more
• UK launches ashwagandha safety consultation as Indian experts step up defense:  Ashwagandha suppliers are being urged to invest in defense as the UK Food Safety Agency (FSA) launches a consultation into the herb and Indian experts refute safety concerns…. Read more

Comment

I, as you undoubtedly have guessed, am a supplement skeptic.  If European agencies are warning against it, I vote for avoiding it, especially if you are in one of the risk categories: pregnant or breastfeeding women, people under the age of 18, and those with endocrine disorders (particularly dysthyroidism and hyperandrogenism), liver or heart problems or undergoing treatment with a central nervous system depressant action.

Supplement sellers can fight back all they like; I urge caution.

I saw this on FoodNavigator–Asia, a newsletter to which I subscribe.

Red yeast rice impact: Kobayashi Pharmaceutical records nearly US$25m losses in Q1: Kobayashi Pharmaceutical reported an “extraordinary loss” of nearly US$25m (JPY$3.86bn) in its Q1 results due to the recall of its contaminated red yeast rice products, raw materials, and compensation of medical expenses. Read more

Red yeast rice is a dietary supplement with a statin-like component observed to reduce blood cholesterol levels, although not nearly to the same extent as statin drugs.  Consumer Lab tests show at least half not to contain what they say they do.

Now, on top of that, the supplements were associated with kidney disease (at least 50 cases) and deaths (at least 2) among takers in Japan.

Comment: Dietary supplements are the wild west of the food supply.  Anyone can make and sell them.  Because they are mainly harmless, nobody much bothers to test them, even major pharmaceutical companies.  Problems with red yeast rice supplements have been known for a long time.  As a result, supplements are risky.  How risky?  Nobody knows.  I don’t recommend them.

The title of this article triggered my usual question: Who paid for this?  I cannot think of any reason other than marketing this supplement for doing a study like this.

Multi-nutrient supplementation of astaxanthin, vitamin E and grape juice improves episodic memory, cognitive performance – RCT:  A study has found that 12 weeks of multi-nutrient supplementation, comprising astaxanthin, vitamin E and grape juice extract, resulted in improved episodic memory and several biomarkers associated with cognitive health…. Read more

The study: Lopresti AL, Smith SJ, Riggs ML, Major RA, Gibb TG, Wood SM, Hester SN, Knaggs HE. An Examination into the Effects of a Nutraceutical Supplement on Cognition, Stress, Eye Health, and Skin Satisfaction in Adults with Self-Reported Cognitive Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024; 16(11):1770. https://doi.org/10.3390/nu16111770

Method: adults aged 40 to 70 years with subjective memory complaints were randomized to take a supplement containing vitamin E, astaxanthin, and grape juice extract daily for 12 weeks or a matching placebo.

Outcomes:  Changes in cognitive tasks assessing episodic memory, working memory, and verbal memory., speed of information processing, attention, and self-report measures of memory, stress, and eye and skin health.

Results: “Compared to the placebo, nutritional supplementation was associated with larger improvements in one primary outcome measure comprising episodic memory (p = 0.037), but not for working memory (p = 0.418) or verbal learning (p = 0.841). Findings from secondary and exploratory outcomes demonstrated that the nutraceutical intake was associated with larger improvements in the Everyday Memory Questionnaire (p = 0.022), increased plasma brain-derived neurotrophic factor (p = 0.030), decreased plasma malondialdehyde (p = 0.040), and increased skin carotenoid concentrations (p = 0.006). However, there were no group differences in changes in the remaining outcome measures.”

Conclusions: “The results from this 12-week study provide some support for the cognitive-enhancing effects of a nutraceutical containing astaxanthin, vitamin E, and grape juice extract in adults with self-reported memory complaints. This was demonstrated by improvements in one primary outcome measure (episodic memory) but not working memory or verbal learning.”